Accutane: From Laudation to Lawsuit

It has been said that Accutane has the ability to clear and prevent acne more effectively than any other medication introduced to the market. Despite this fact, many now say that Accutane should never have been offered as a treatment for blemishes, since its slew of serious side effects clearly outweigh any benefits to the complexion. Accutane has been proven to severely damage the digestive tract and to cause birth defects in the unborn children of pregnant consumers. Faced with hundreds of lawsuits from patients who suffered these side effects, Roche (the manufacturer) finally issued an Accutane recall.

Accutane: The Good, The Bad

Accutane falls into the category of retinoids, indicating a derivative of vitamin A. Its skin-clearing ability is due to its effect of greatly reducing oil production in the skin’s sebaceous glands and other areas. Accutane, also known by its generic moniker Isotretinoin, passed muster with the FDA in 1982. From the beginning, it proved to be amazingly effective at treating and preventing acne, and it enjoyed an unprecedented 85 percent success rate. Numerous reports and praise calling Accutane a ‘miracle drug’ ensued. The man said to be responsible for its discovery, Dr. Gary Peck, received several acclaimed awards for his work.

Following close on the heels of praise and profits (to the tune of hundreds of millions of dollars each year) were disturbing reports of “teratogenic” side effects, or side effects that cause malformation in embryos. Close to 30 percent of all pregnant women taking Accutane witnessed their babies born with birth defects as a result. Even more disturbing was the fact that many doctors were not performing adequate pregnancy tests before prescribing the drug to women.

Reducing Accutane Birth Defects

In order to fight the nightmare of Accutane birth defects, the FDA decided to create a program named iPLEDGE in 2006. This program spelled out regulations that required not one but two consecutive negative pregnancy tests for any female patient wanting a prescription for Accutane. In addition, women were obliged to promise that they would use two forms of birth control before they were allowed to begin taking the drug.

Other Accutane Side Effects Appear

There was no program or list of guidelines the FDA could come up with that could prevent the other side effects that resulted from taking Accutane. It was discovered that the quantities of the drug frequently prescribed by doctors were sufficient to alter the delicate chemical balance of the digestive system. In particular, a direct link between Accutane and gastrointestinal disorders such as inflammatory bowel disease (IBM), Crohn’s disease, and Accutane ulcerative colitis was proven by several studies. All of these conditions can lead to colon removal, which of course has a permanent detrimental effect on quality of life.

Accutane Recall

Ultimately, after selling more than 13 million prescriptions, drugmaker Roche initiated an Accutane recall and retired the drug from the market. According to the manufacturer, this action was due to economic reasons, which may be due fully or in part to the hundreds of Accutane side effect lawsuits that have been filed against them.

Depression: Accutane's Deadly Side Effect

Accutane's Deadly Side Effect

In a letter sent to doctors in February 1998, Roche Laboratories, makers of Accutane, warned that among the various side effects Accutane is known to produce in users, severe depression and suicide are known to occur. Accutane, a successful and popular acne treatment medication, had been on the market longer than 15 years at that point, and patients and dermatologists praised its ability to effectively clear serious acne.

In the letter it was stated: “Accutane may cause depression, psychosis and, rarely, suicidal ideation, suicide attempts and suicide.”

Depression Linked to Accutane Use for Years

The information circulated by Roche in 1998 was anything but a recent discovery. Depression had long been a known side effect of Accutane, and had been included, although briefly, on the drug’s warning label since 1985. There are multiple side effects associated with Accutane use, and some others include ulcerative colitis, inflammatory bowel disease, and Crohn’s disease.

The FDA was not impressed with Roche’s letter to physicians. They had long been aware of the risk of Accutane depression, as evidenced by hundreds of complaints filed with the agency. It was obvious that the American public had a right to a stronger warning.

New Millennium Sees Reemergence of Accutane Depression Issue

Once again in September 2000, the FDA made public the link that exists between Accutane and serious depression. Before a meeting of the FDA’s Dermatologic and Ophthalmic Drug Advisory Committee, medical experts declared Accutane use had been related to 147 suicides and hospitalizations brought on by depression between 1982 and 2000. Roche argued against those claims, stating that a much higher suicide rate would naturally occur in a group study.

While defending against accusations of Accutane depression and suicide, Roche had brought to light a troubling fact: Accutane was largely prescribed to teenagers, a portion of the general population particularly sensitive psychologically. Teens are already more susceptible to depression, and suicide is ranked third as the cause of teen deaths, behind car accidents and homicide. It has been proven that Accutane can worsen preexisting psychological issues.

Despite defending its product, Roche withdrew Accutane from the American market in June 2009. The company, which is based in Switzerland, did not release a statement referring to depression or any of the other well-known Accutane side effects. There was, in fact, no need to speak of the side effects or the recall: the damage had already occurred. More than 13 million prescriptions had been sold over the years, thousands of people had suffered from illnesses brought on by Accutane, and some had lost their lives.

Currently, there are thousands of Accutane lawsuits pending in the U.S. court system.

Accutane Troubles are More Than Skin Deep

Accutane was a prescription acne medication used for the treatment of severe acne that did not respond to other treatments such as antibiotics and topical ointments. It was pulled from the market by its manufacturer, Hoffman-La Roche, in 2009. Hoffman-La Roche cited generic competition as the reason behind the pulling of the product, but there are certain other factors in the Accutane lawsuit case that may also have fueled the recall.

Lawsuits have been pouring in from across the country for years, and Hoffman-La Roche has already paid millions of dollars in settlements to plaintiffs who are insisting that doctors and Hoffman-La Roche did not do enough in terms of warning patients about the risks of Accutane before actually prescribing it. In the case of one Alabama man whose intestinal problems from Accutane were so bad he was forced to have his colon removed, the company paid $25 million after an appeal in settlements to him.

Side effects related to Accutane are often intestinal in nature and include ulcerative colitis, Crohn’s disease, and inflammatory bowel disease. It has also been associated with miscarriage and severe birth defects and problems with eyes, skeletal system, ears, and liver. Serious psychiatric problems have also been reported to be associated with Accutane, and some lawsuits involve patients or families of patients who either considered, attempted, or committed suicide.

Although nearly 50 million people in the United States suffer from acne, and it is the most common skin disorder in the United States, Accutane was meant to be prescribed only in severe cases – however, up to 90 percent of women and almost half of teens who were taking Accutane only had mild cases. About 13 million people were prescribed Accutane in total. It is not known how many lawsuits will go through the legal system before trials end, but it looks like it’s going to be an expensive few years for Hoffman-La Roche.